Implantable medical devices hpra.ie How to report an incident to the HPRA The Health Products If your medical device poses a risk to your health Regulatory Authority (HPRA) and safety, please report the problem to your health Our role is to protect and enhance public and animal care provider, the HPRA and the manufacturer of the health by regulating medicines, medical devices and device. You should report any unexpected problem other health products. or malfunction that may affect your health or cause MEDICAL DEVICES or contribute to an injury, for example, poor vision following a lens implant where your doctor assesses the problem could be due to the lens. What does the HPRA do? Implantable As the regulatory authority, we monitor the safety of You can report incidents to the HPRA by filling in our all medical devices available in Ireland. Our aim is to medical devices online user report form on www.hpra.ie. If you would make sure that these products do not compromise the prefer to fill out a printed copy of the form, you can health and safety of the patient or the person using download it from our website or request a copy by them. We also work to ensure that medical device phone or e-mail. manufacturers comply with all safety regulations. (The HPRA cannot provide advice on which medical Our More information devices you should buy.) advice This is one in a series of information leaflets that you can get from the HPRA and from our website: www.hpra.ie. You can also get more information on the Irish Heart Foundation website: www.irishheart.ie, and the Diabetes Federation of Ireland website: Kevin O’Malley House www.diabetes.ie. Earlsfort Centre Earlsfort Terrace Dublin 2 Phone: (01) 676 4971 Fax: (01) 634 4033 E-mail: [email protected] www.hpra.ie www.hpra.ie Implantable medical devices hpra.ie OUR ADVICE oN • Take all the medication your doctor prescribes. If • If you have a pacemaker or ICD, it is not safe to you have artificial heart valves or some types of walk through airport security systems or to be Implantable stent, you will need to take long-term medication scanned with a hand-held security wand. Show your to prevent blood clots. Do not stop this medication official ID card to airport security staff. It is safe to medical devices unless your doctor tells you to. If you have any walk through shop security systems at a normal side effects from your medication tell your doctor pace, but do not sit or stand nearby. An implantable medical device is one without delay. • In general, household equipment such as that is placed inside your body during microwave ovens and computers are safe to use, a medical procedure, such as surgery, Tips for pacemakers, ICD and but always check the manufacturer’s instructions. and is intended to stay there after implantable drug pumps • It is safe to use mobile phones, but hold them to the procedure. the ear opposite your implant and do not carry • Always carry your device ID card with your name them in your breast pocket. and details of your device. • Avoid wearing magnetic bracelets and magnets Examples of implantable devices include cardiac • You must tell health professionals, doctors, nurses near your chest. pacemakers, implantable cardiac defibrillators (ICDs), or dentists about your device, as you may need to coronary stents, hip implants, interocular lenses avoid some medical tests and treatments such as and implantable insulin pumps. Some implantable CT, MRI scans and TENS devices. Device details medical devices, such as a pacemaker, may be • You should tell your family and close friends that battery-powered. Use this form to record the essential details about you have an ICD, a cardiac pacemaker or an your device: implantable drug pump. Tell them what to do if you lose consciousness or collapse. General tips Your name: • If your device has a battery, ask your doctor how • Make sure you understand what your device does you will know when the battery needs to be Name or type of device: and why you need it. replaced or recharged. Make sure you know what to • Talk to your doctor about what to expect during do when the batteries in your device run low. Date of implant: your recovery period. Ask them when you will be fit • Batteries are recharged or replaced in hospital. Model or serial no: for work, fit to drive and fit to travel. Know when, where and who you need to attend • Ask your doctor about follow-up care and who to have this done. You may need to replace the Consultant or hospital phone no: you should contact if you have any problems in batteries in the remote control of some devices. the days after your procedure, such as excessive Make sure you know where to get replacements. Follow up contact person in case of problems: bleeding, bruising or significant pain at the implant • Some powered devices may be affected by or wound site. electromagnetic interference from security Phone no: • Keep all follow-up appointments. Powered devices systems, electricity generators and arc welding such as cardiac pacemakers and ICDs need to have equipment. Follow your device manufacturer’s Other notes: batteries, wires and software checked regularly. safety recommendations. Make sure that electricity generators and arc welders are grounded and leave the area immediately if you feel light headed or faint. .